One of the most common complications encountered with external fixation devices is pin tract infection in post-operative patients. Treatments for this type of infection normally include oral antibiotics, hospitalization for administration of intravenous antibiotics, and in some cases, when the infection is severe treatment includes pin removal.
External fixator pin care currently employed ranges from doing nothing, to using ointments, to pouring saline on the pin sites several times daily, and to use of antiseptic lotions to cover pin sites, etc. The patients are usually warned that if there is any redness or pain around a pin site associated with the increase of purulent discharge, the patient is instructed to return to hospital or doctor for starting of a regimen of antibiotic treatment. Nevertheless, despite their continuing infection risk external fixator pins are known to provide definite and significant orthopedic aid; they are therefore used routinely.
The use of such external devices transfixed through bone to hold the position of a fracture indeed is not new. The pins in plaster method has been used for many years to hold bone fragments in proper position during the healing process. More recently, there has been increased utilization of multiple pins placed through one cortex or both cortices of bone, held by a unilateral, bilateral or circumferential fixation device. For example, Ilizarov circumferential fixation is used for lengthening or bone transport, and EBI.RTM. unilateral fixation is often used for forearm fractures. These fixators allow easy access to wounds, adjustments during the course of healing, and enhance functional use of the limb involved during healing.
With such devices as those above listed, the most common complication encountered is infection at the pin site. Commonly, hospitalization for intravenous antibiotics will occur over a five-day period and is quite expensive. The occurring high incidence of infection and common requirement for hospitalized treatment is a result of the lack of a uniform pin site care protocol which can be consistently and regularly practiced with a high degree of patient compliance. Indeed, a quick review of the literature indicates significant variations are noted in existing protocol designs, and that the majority demand large amounts of supplies, great expense, and much time on the part of the patient.
Some of the more common cleansing methods practiced to one degree or another in the known prior art are:
(1) Cleaning pin sites with tap or soap water, one to four times daily; PA1 (2) Spraying each pin site with normal saline, using sterile syringes; PA1 (3) Cleansing with 100% peroxide alone or in conjunction with a Betadine ointment; PA1 (4) Pouring sodium chloride over the pin site four times daily; PA1 (5) Applying antibacterial ointment or antiseptic ointment only; PA1 (6) Changing dressings one or two times daily without specific cleaning of the pin site; PA1 (7) Cleaning pin sites one to four times daily with Hibiclens or Betadine solution and covering with sponges or dressings; and PA1 (8) Showering.
The problems associated with these methods include cross-contamination of the pin sites, the sealing in of infectious process by ointments, allergies to the cleaning agents, skin irritations caused by the cleaning agents, availability of supplies, no specific contact person for problem solving, and the requirement for numerous clinic visits.
It can be seen that there is a continuing need for an uncomplicated and effective pin site care protocol which decreases infection risk and increases patient compliance. It is a primary object of this invention to fulfill this need.
Another object of this invention is to provide a low-cost kit and regimen that can use widely-available cleaning supplies.
Another object of the invention is to provide a clear and concise set of written instructions for patient education.
Yet another object of the present invention is to provide decreased need for post-operative medical intervention.
An even further object of the present invention is to provide universal treatment procedures from a single kit for circumferential fixators, unilateral fixators, pelvic fixators, halo-fixation, skeletal traction and Gardner-Wells fixation.
A further object of the present invention is to provide a kit which will allow for patient involvement in their own care in a manner that is more effective than the random treatment processes now commonly used for pin site care.
A still further objective is to provide all of the above objects using materials that are hypoallergenic and using solutions that do not cause allergic reactions in most patients.